2025. Osmunson B. 2025. SUBMISSION. Before the Washington State Board of Health. Supplement to Petition #24 – Institutional Conflict of Interest and the Ethics of Self-Review in Community Water Fluoridation. November 6.

Excerpt

Principles of Independent Ethical Oversight 

The Belmont Report (1978) established that credible ethical oversight must be independent of those administering a program. Similarly, the World Health Organization (2011) and the American Public Health Association (2019) emphasize that ethics evaluations must be conducted by individuals “independent of the interests, command structure, or financial incentives of the agencies being reviewed.” 

Organizational loyalty, employment dependency, and professional identity all compromise the ability of employees to critique their agency’s actions objectively. As Kunda (1990) and Tenbrunsel & Messick (2004) demonstrated, institutional affiliation fosters motivated reasoning—the unconscious filtering of information to support prior beliefs and preserve social standing. Under these conditions, any internal review of fluoridation ethics would predictably reproduce the same rationalizations that led to the initial failure to assure safety. 

Liberty (freedom from oppressive authoritarian restrictions) is not a luxury of public health; it is its foundation. Without autonomy for none highly contagious or lethal diseases — such as dental caries– becomes a public health police powers kingly act. The rediscovery of public health liberty begins with honesty — the willingness to tell patients the whole truth even when it contradicts official policy, industry profits, or a patient’s bad choice. 

Fluoridation is not just a loss of patient liberty, it is unethical. By attempting to create better health through chemistry rather than patient education and incentives, focuses on one disease 

rather than overall health. For example, dental caries is an early symptom of poor health. A reduction in refined sugar and oral hygiene will improve several diseases such as periodontal disease, diabetes, obesity, etc. 

The true harm to public health in our war over fluoridation is the time, money and resources spent on one “symptom” rather than overall good health. It is past time we focus on good health rather than just one symptom of poor health. 

Public-health ethics is grounded not only in beneficence but in respect for autonomy. Liberty—freedom from coercive state intervention—is not a luxury but the foundation of legitimate public health. Compulsory exposure to a pharmacologically active substance to address a non-contagious condition, without informed consent or individualized risk assessment, exceeds ethical limits on state power. True ethics begins with truth-telling and shared decision-making, not coercion. Every act of informed consent is an act of civilization; every act of compulsion erodes it. 

Regulatory and Professional Parallels 

The principle of independence is codified throughout law and ethics: 

  • Institutional Review Boards (IRBs) are prohibited (45 C.F.R. §46.107[e]) from reviewing research in which members have conflicts of interest. 
  • Judicial ethics (Canon 3C, Code of Conduct for U.S. Judges) require recusal when prior advocacy or relationships may affect impartiality. Most of the fluoridation panel members should have recused themselves. 
  • Federal ethics regulations (5 C.F.R. §2635.101[b][14]) require employees to avoid even the appearance of partiality. 

By these standards, any fluoridation ethics panel composed of Department or Board employees—especially those with prior promotional roles—cannot meet the threshold of independence or public trust. 

Fluoridation as Unconsented Human Research 

Some argue CWF is not research, but under 45 C.F.R. §46.102(l) and the Belmont Report, research is “a systematic investigation designed to develop or contribute to generalizable knowledge.” Fluoridation meets this definition: 

  • Intent: To prevent a medical condition (dental caries) via systemic ingestion of a pharmacologically active ion. 
  • Design: Population-wide exposure without dosage control, labeling, or informed consent. 
  • Outcome: Ongoing data collection and publication of exposure-effect findings—constituting continuous human experimentation. 

Under 21 U.S.C. §321(g)(1)(B), fluoride intended to prevent disease is a drug. Administering it without FDA New Drug Application (NDA) or Investigational New Drug (IND) authorization constitutes unapproved human experimentation

However, no authority has accepted responsibility for the unapproved human research and few are even evaluating the success, risks, harm, or safety of fluoridation. 

The Belmont Report, Nuremberg Code, and Helsinki Declaration require voluntary informed consent for any exposure of uncertain safety. Because fluoridation’s safety has never been confirmed by randomized controlled ingestion trials, it remains unconsented population research. Furthermore, the exemption in 45 C.F.R. §46.101(b)(5) applies only to programs lawfully authorized and approved by a department head—conditions unmet here. As Hans Jonas (1969) warned, population-wide interventions of unknown outcome constitute de facto human experimentation. 

Ethical Evaluation Requires Evidence of Benefit and Certainty of Safety 

Ethical judgment depends on credible scientific evidence. As Kass (2001) and Royo-Bordonada (2015) observe, beneficence cannot justify interventions lacking proven safety. 

  • Certainty of Benefit: The Cochrane (2024) update found low-certainty evidence of caries reduction under current exposure conditions. 
  • Certainty of Safety: The NTP (2024) report, Grandjean (2024), and NRC (2006) review indicate potential developmental neurotoxicity within common exposure ranges, particularly for fetuses and infants. 
  • Certainty of Harm: The threshold for known adverse effects (e.g., IQ loss) overlaps existing exposure levels, eliminating any meaningful safety margin. 

RCW does not mandate the Board or Department to weigh or judge the balance of efficacy vs safety. Benefit is the jurisdiction of the FDA. RCW is focused on certainty of safety. 

Where safety is unassured and efficacy uncertain, ethical justification collapses. The Nuffield Council on Bioethics (2007) held that population measures overriding autonomy require robust evidence of benefit and minimal risk. The Public Health Agency of Canada (2018) and CADTH (2019) similarly concluded that fluoridation ethics cannot rest on unverified assumptions of safety or efficacy. 

Ethical Imperative for External Review 

An internal ethics panel within a conflicted hierarchy cannot restore public trust. The Board’s statutory duty under RCW 43.20.050(2)(a)—to assure the safety of public drinking water—requires evidence beyond reasonable doubt before exposure. Self-affirming reviews fail that standard. 

Ethical legitimacy requires an independent, multidisciplinary external review empowered to evaluate both scientific and moral claims without institutional constraint or predetermined outcome. 


2025. Osmunson B. 2025. SUBMISSION. Before the Washington State Board of Health.Petition #24 – Assurance of Safety Communications for Fluoride Additives in Public Drinking Water. October 15.

2025. Osmunson B. 2025. SUBMISSION. Washington State Department of Health Community Water Fluoridation Panel :  Rebuttal & Public Comment. September 28.

2024. Osmunson B, Cole G. 2024. Community Water Fluoridation a Cost–Benefit–Risk Consideration. Public Health Challenges, Nov 27; 3(4):e70009.  On FAN.

2023. Osmunson B. 2023. SUBMISSION to the National Toxicology Board of Scientific Counselors Regarding: Draft NTP Monograph on the State of the Science Concerning Fluoride Exposure and Neurodevelopmental and Cognitive Health Effects: A Systematic Review NTP Monograph. April.

2019. Neurath C, Limeback H, Osmunson B, Connett M, Wells CR. 2019. Response to Letter to the Editor: “Dental Fluorosis Trends in US Oral Health Surveys.” JDR Clinical & Translational Research ,Oct 7; 5:1.

2019. Neurath C, Limeback H, Osmunson B, Connett M, Wells CR. 2019. Resolving Questions About the Validity of the CDC’s Fluorosis Data. 2019. JDR Clinical & Translational Research, Aug 22; 4(4):310-311.

2019. Neurath C, Limeback H, Osmunson B, Connett M, Kanter V, Wells CR. 2019. Dental Fluorosis Trends in US Oral Health Surveys: 1986 to 2012. 2019. JDR Clinical & Translational Research, Mar, 4:4.

2017. Neurath C, Beck JS, Limeback H, Sprules GW, Connett M, Osmunson B, Davis DR. 2017. Limitations of fluoridation effectiveness studies: Lessons from Alberta, Canada. Community Dentistry and Oral Epidemiology, Oct; 45(6):496-502.

2017. Osmunson B. 2017. Like a knee in the gut. British Dental Journal, Mar 10;222(5):324. March 10.

2016. Osmunson B, Limeback H, Neurath C. 2016.  Study incapable of detecting IQ loss from fluoride. American Journal of Public Health, Feb;106(2):212-3. On FAN.

2014. Neurath C, Peckham S, Limeback H, Micklem HS, Osmunson W. 2014. Unreliable data. British Dental Journal, July 25; 217(2):55.

2014. Osmunson B. 2014. Presentation at the Fluoride Action Network conference.

2013. Neugeboren SM. 2013. Letter to Gerald Steel, PE. February 14, 2013.

2011. Osmunson B. 2011. Submission to the EPA, HHS, and CDC: EPA Dose-Response Analysis and Exposure and Relative Source Contribution Analysis.

Professional Perspectives on Water Fluoridation

2009. Are kids being overdosed on fluoride?

2002. Osmunson B. 2002. Vertical dimension of occlusion in implant dentistry: significance and approach by Dr. Gittelson. A neuromuscular approach by Dr. Osmunson. Comment. Implant Dentistry, 11(3):202-10; discussion 211-4.

1979. Castle DP and Kennedy D. 1979. Memorandum of Understanding between the Environmental Protection Agency and the Food and Drug Administration. June 1979. https://fluoridealert.org/wp-content/uploads/osmunson-hhs.appendix-1.pdf